Good afternoon, everyone, to those who's based in the UK, and good morning to all of those in the US at the start of your day. My name is David Redfern. I'm President of Corporate Development for GSK and the Chairman of ViiV Healthcare. I'm delighted to host this Meet the Management event focused on our HIV business for analyst investors. As usual, the materials presented today are available on gsk.com. You should see in front of you now the title slide of this presentation, Getting Ahead of HIV Together. I should just say that we are now in the closed period, and therefore, we will not be making any comment today on performance matters relating to the current quarter. Those will be covered in the GSK Q3 results reported shortly. I would just refer you to slide two, which contains our cautionary and forward-looking statements.
Moving on to slide three, which is a summary of what we shall cover today. I'm delighted to be joined by Deborah Waterhouse, the CEO of ViiV Healthcare and President of GSK Global Health, and Dr. Kimberly Smith, Head of R&D for ViiV. The following 90 minutes will be divided into two parts. For the first 45 minutes, we will walk you through how we are reshaping the HIV treatment and prevention market, the shape of our HIV business, with a specific focus on consolidating our leadership position in long-acting, and our continued innovation leadership and our pipeline. Following that, we will have plenty of time for Q&A. I would also like to remind you that this call is being recorded and that will be made available after the event. We are now on slide four.
ViiV Healthcare is a joint venture between GSK, Pfizer, and Shionogi, and is 100% focused on treating, preventing, and ultimately curing HIV and AIDS. GSK and its predecessor companies have been at the forefront of HIV innovation for more than 35 years now. GSK was proud to develop the world's first medicine, AZT, to treat HIV infection in 1987, followed by the first fixed-dose combination, Combivir, in 1997. ViiV Healthcare was created in 2009 and is dedicated to discovering, developing, and commercializing medicines to treat and prevent HIV worldwide. We are proud of our deep and authentic partnerships with grassroots community organizations who are leading the HIV response globally and often in challenging environments where discrimination and stigma remain highly pervasive.
Our flagship Positive Action team has recently celebrated 30 years of supporting the HIV community, and we dedicate significant efforts to ensuring our recruitment programs bring diversity and inclusion across our teams, reflect the communities we serve, and amplify the voice of people living with HIV in everything we do. In 2013, ViiV launched dolutegravir, which transformed the treatment of HIV by becoming the world's leading integrase inhibitor and continues to be at the forefront of our innovative portfolio today. Four years ago, we again transformed the treatment paradigm by launching Dovato, the leading oral two-drug regimen powered by dolutegravir at the core. Within the last few years, we have launched Cabenuva, the world's first and only complete long-acting injectable regimen for the treatment of HIV. Apretude, the world's first and only long-acting injectable for the prevention of HIV.
We have a long and very proud history of leading innovation in HIV, in pursuit of our mission to leave no person living with HIV behind. With that, I will now hand over to Deborah, the CEO of ViiV Healthcare.
Thanks, David. We are on slide five. I'm now going to provide an overview of how we are reshaping the HIV treatment and prevention market. I want to add how proud we are to be featuring authentic voices throughout this presentation of people living with HIV or who could benefit from PrEP. So let's hear from Jason, a U.S. military veteran living with HIV and currently taking Cabenuva.
My name is Jason. I'm HIV positive, and I was diagnosed in 2001. I remember when the doctor gave me the diagnosis, and by the time I got home, it had really kinda sunk in that, okay, this is, you know, life-changing. My initial pill regimen for several years was one pill once a day, usually at night, and that went on for a long, long time. And sometimes that pill is a big reminder of being HIV positive and this virus in your body. I've been on Cabenuva, and in my opinion, it's been fantastic. It's really nice not to have to rush home and take a pill. To not have to take pills anymore, that was huge.
Once I knew there was something that you had a choice, I was like, "Sign me up." For me, a quick change in plans on Cabenuva doesn't mean anything. I don't have to worry about it. I can continue on with what I was doing and adjust and adapt and take advantage of new opportunities. It really is freedom. Cabenuva is two injections given by my healthcare provider every other month. So it's six times a year, you go to the doctor, and it helps keep me undetectable. So I know every eight weeks on a Tuesday, I'm gonna have my appointment. The appointment's already set. I'm a planner, so I plan it out, and I know what I'm doing. It's important to hit your target date, but if you can't hit that date, you can hit it a week before to a week after.
So it works out very well. Then the injection itself really doesn't take that long. It's a relatively quick visit. It's an office visit. It's a chance for me. I like the connection with the doctor, my doctor, and the medical staff. They get a chance to see you more with this regimen, and so, like, "How are you feeling? You know, is everything okay? What's going on in your life?" This is 20 years for me in August since I was diagnosed, and I'm gonna live to be an old man, probably, you know, hopefully. And so it's really meaningful to me to leave a legacy for people who are HIV-positive.
Jason's story is one that we hear time and time again. People not just living with HIV, but now thriving due to the innovation of our long-acting injectable Cabenuva. We are now on slide seven, which provides a summary of the key commitments we made at the ViiV Investor Update, which was held in November 2021. As a reminder, we outlined an ambition to remain innovation leaders in HIV, delivering progressive acceleration of growth and achieving a mid-single-digit CAGR to 2026. Through competitive execution, we have driven above-expectation growth for Dovato and our long-acting portfolio, Cabenuva and Apretude. As we move into the second half of the decade, we are confident we will see a significant acceleration in the uptake of our long-acting regimens, with cabotegravir replacing dolutegravir as the foundational medicine in our portfolio.
We are excited about our pipeline progress, which Kim will cover, which has the potential to significantly replace the revenue from dolutegravir post-loss of exclusivity. Please turn to slide eight. Today, I am delighted to confirm that as a result of our strong and competitive execution and innovation leadership, we are in a position to upgrade our 2021-2026 sales CAGR from mid-single digit to a higher range of between 6%-8%. This upgrade includes the impact of the US Inflation Reduction Act of up to one percentage point of growth. In November 2021 update, we committed to delivering every 3-monthly dosing in treatment and prevention. I am delighted to share that we expect to exceed that ambition, and we are now fully focused on delivering in every 4-monthly injectable regimen.
This is significant as it enables us to double the dosing intervals of what we have in our hands today with Cabenuva and Apretude, and meaningfully increases the benefit of long-acting regimens for patients and healthcare professionals. For prevention, we will file a launch in 2026 and for treatment in 2027, enabling clinic visits to be halved to just three per year. This stands in stark contrast to those patients currently taking daily oral therapy, who have to remember to take their tablets 365 times every year. Through the acceleration of our research efforts, we are now able to provide greater clarity on our roadmap to further extend the dosing interval of our long-acting regimens in treatment and prevention, to enable every six-monthly dosing towards the end of the decade.
This would result in patients only needing to visit the clinic two times a year. And finally, we will demonstrate our confidence in our ability to navigate through the revenue impact associated with the loss of exclusivity of dolutegravir. This will be delivered through increased momentum in the growth of our long-acting portfolio and clear demonstration that the intellectual property for Dovato and Juluca has potential to extend through the end of the decade. I will now share how strong commercial execution is driving growth on slide nine. Please move to slide 10. Strong commercial execution drives our 2021-2026 CAGR to a higher range of between 6%-8% at constant exchange rates, with forecasted total sales now increasing from GBP 6 billion - GBP 7 billion in 2026.
Starting on the left of the slide, growth drivers 2021 to 2026. Market performance firmly reflects prescriber belief in Dovato, which today is our number one selling HIV medicine. Our long-acting portfolio, Cabenuva and Apretude, is ahead of expectation and on track to deliver more than GBP 2 billion of sales in 2026, representing around one-third of our HIV total sales. Cabenuva is the world's first and only complete long-acting regimen for the treatment of HIV. Cabenuva continues to be supported by strong label evolution and data, which underpins confidence. Patient awareness of Cabenuva is high at over 70%, and more than 50% of switches are coming from Biktarvy. Apretude is the world's first and only long-acting injectable for the prevention of HIV, dosed every 2 months.
It was launched in the US in January 2022, and we've had high levels of ambition for this medicine. Our Phase III data for Apretude demonstrated superiority in both pivotal men and women studies, which were stopped early for superior efficacy versus standard of care, and HCP confidence in the potential of this medicine is very high. As we move to the right of the slide, 2026-2031, our ambition is to remain innovation leaders in HIV, and cabotegravir will replace dolutegravir as the foundational medicine in our portfolio. Our pipeline is focused on three target product profiles: ultra-long acting for treatment and prevention, with dosing intervals of four months or longer, and the world's first self-administered long-acting regimen for treatment. Please move to slide 11.
ViiV Healthcare is the fastest-growing company in HIV, growing at 12% in Q2 and 14% in the first half of 2023 at constant exchange rates. In the last year, we've increased our global market share by two percentage points. Our portfolio continues to transform the HIV marketplace, delivering on individualized patient needs. Dovato continues to grow strongly, enabling people living with HIV to remain virally suppressed with fewer medicines. We are confident that this innovative oral two-drug regimen is on track to deliver GBP 2 billion in sales in 2024. Our long-acting injectable portfolio, consisting of Cabenuva and Apretude, continues to transform the paradigm in HIV treatment and prevention. Long-acting portfolio sales are on track to more than double in 2023, and we expect sales to now exceed GBP 2 billion in 2026.
This is above the expectation we set out in the business investor update in 2021. Cabenuva addresses the significant challenges with daily therapy: fear of HIV status disclosure, stress and anxiety about staying adherent, and the constant reminder of living with HIV. As we heard from Jason earlier, long-acting gives people freedom. 23,000 people living with HIV are taking, are now taking Cabenuva in the U.S. and a further 17,000 across Europe. HIV physicians are guided by data and guidelines, and we could not be more proud of our robust and industry-leading studies. Earlier this year, we were delighted by the response to the presentation at CROI of our SOLAR data, which demonstrates that Cabenuva is as effective as Biktarvy, Biktarvy for the treatment of HIV.
Importantly, the 12-month findings demonstrated that nine out of 10 participants who switched from Biktarvy to Cabenuva preferred the complete long-acting regimen to daily oral pills. Apretude has the potential to transform the PrEP landscape and play a role in ending the HIV epidemic. Patients tell us that Apretude gives them freedom, as shown by the fact that 96% of phase III study participants chose to transition to Apretude over the daily oral standard of care in the open label extension phase of the study. This, alongside a desire by prescribers, payers, and governments for a new solution to help end the HIV epidemic, gives confidence that the PrEP market will continue to grow strongly. Compelling data for our long-acting injectable portfolio has resulted in 84% of US healthcare prescribers concluding that long-acting regimens will now become a key part of HIV care.
We are now on slide 12. I will now walk you through the expected shape of our HIV business and how the shift to long-acting and extended period of exclusivity reduces the impact of the anticipated dolutegravir loss of exclusivity. The pie chart you see on the left paints a picture of the projected shape of our business in 2027. We expect our business will have moved to a portfolio balanced between orals and long-acting regimens, with our long-acting portfolio representing around 40% of our revenue. As we move to the bar chart, I would like to spend a few moments describing our intellectual property, which should help to clarify expectations around the timeline of dolutegravir's loss of exclusivity. In Europe, which accounts for around 40% of the dolutegravir-based revenue, the composition of matter patent expires in July 2029.
The U.S. represents around 60% of our dolutegravir-based revenue. In the U.S., dolutegravir is protected by a composition of matter patent until April 2028, which includes an additional six months of exclusivity following the completion of our pediatric studies. Dovato and Juluca are also protected by formulation and other patents in the U.S., which have expiry dates after the composition of matter patent. Therefore, we anticipate a longer exclusivity period in the U.S. for Dovato until December 2029 and Juluca until July 2030, protecting around 35% of dolutegravir-based regimen revenue.
Additionally, the current cabotegravir formulation in Cabenuva and Apretude is protected by composition of matter patents until February 2031 in the U.S. and April 2031 in the E.U., which with the potential for an additional six months of six months extension for pediatric exclusivity. There is also potential for patent protection for future long-acting formulations and regimens extending further into the 2030s, depending on the regimen selected for ultra-long-acting treatment and prevention. Please turn to Slide 13, where I will expand on how we intend to reshape the market towards long-acting. We are now on Slide 14. Key challenges remain in the treatment and prevention of HIV. The World Health Organization estimates approximately 1.5 million new infections per year globally, with the burden remaining greatest in Sub-Saharan Africa.
Across America, it is estimated that around half of people living with HIV are virally suppressed, and there are still 38,000 new infections per year. HIV rates are stubbornly high among people of color and men who have sex with men. As such, there remains a pressing need for new approaches to treatment and prevention. Industry pipelines are dominated by long-acting regimens. U.S. patient demand for a long-acting injectable for PrEP is high. The stigma around PrEP use and the perceived hassle of daily dosing are currently top drivers of discontinuation of PrEP. Prescribers express concern about their lack of ability to observe adherence with current PrEP options, and cabotegravir addresses these concerns. In the U.S., less than 25% of those who would benefit- who could benefit from PrEP are currently taking PrEP.
We remain mindful of broader shifts in the reimbursement and payer environment, and specifically, the introduction of the U.S. Inflation Reduction Act. We are highly conscious of the need to continue to price our medicines responsibly, and are proud of our access to medicines efforts, which are focused on enabling our medicines to reach those who need them, irrespective of location or ability to pay. Please turn to Slide 15. As we move through the decade, we anticipate driving a fundamental shift in the HIV market towards long-acting injectables. In treatment, we envisage the market will move from being dominated by oral regimens to a more balanced position, with long-acting injectable regimens representing around 30% of the market value by 2021. In prevention, we believe that long-acting injectables will grow to around 80% of the value by 2031.
In the US, we expect the market to more than double over the next decade to reach GBP 4 billion-GBP 5 billion, supporting the US government's ambitious goal to end the HIV epidemic by 2030, and to reduce new infections by 75% by 2025. As stated, our ambition is to remain innovation leaders in HIV, and through the changing mix of our portfolio towards long-acting and the success of our pipeline, we have the potential to significantly replace the revenue from dolutegravir post-loss of exclusivity. I will now hand over to Kim to walk you through our pipeline focused on the next wave of innovative, long-acting regimens.
Thank you, Deborah. We are on slide 16. We'll be updating you on the future pipeline, looking ahead to 2027 and beyond. We continue to be the leaders in long-acting therapies for HIV. Long-acting is the future, and we collected a large body of data directly from patients who are telling us about their experience with the first and only long-acting regimens for HIV treatment and prevention. In 2021, we made commitments for our next wave of long-acting regimens, and our early pipeline is progressing well. Please turn to Slide 17. Our journey map shows the history of our products and pipeline. It outlines our commitment to leaving no person living with HIV behind, and is best illustrated by our development of Rukobia for multi-drug-resistant patients and the development of Triumeq PD, the first and only fixed-dose regimen for children living with HIV.
The journey map also outlines our innovative oral two-drug regimens and the first and only long-acting regimens for HIV treatment and HIV prevention, which have changed the HIV therapeutic landscape. We will highlight our future target product profiles or TPPs, and our portfolio of assets in current and new mechanisms of action. Finally, at the peak of our journey map is HIV cure and remission. We remain invested and committed in being part of getting to the cure for HIV through our own discovery, organization, and collaborations with academic researchers. Please turn to Slide 18. Our TPPs are driven by patient insights and patient demand and unmet need. Based upon these insights, we are focused on three TPPs: ultra-long-acting prevention, ultra-long-acting treatment, and long, long-acting self-administration. The first TPP is ultra-long-acting prevention.
In the United States, only 25% of the people who could benefit from HIV prevention are currently receiving PrEP. We believe that Apretude today, and in the future, ultra-long-acting PrEP, will substantially improve on that statistic. Second TPP is ultra-long-acting treatment, which will decrease clinic visits and clinic resource utilization. This will help providers who have told us that they would like more capacity to administer long-acting therapy to more people. Ultra-long-acting treatment will build on the game-changing impact of Cabenuva. The third TPP is long-acting self-administration, which is for individuals who want more control, who are open about their status, and who want more freedom from clinic visits. Please move to slide 19. Our current marketed products and our future pipeline are built on the foundation of integrase inhibitors.
Integrase inhibitors are the gold standard anchor agents that are trusted by healthcare providers worldwide due to their superior potency, efficacy, long-term tolerability, and high barrier to resistance. Nearly 23 of 28 million people living with HIV who are on treatment around the world are on a dolutegravir-based regimen. Millions more are on other integrase inhibitors. Cabotegravir is the world's first and only approved long-acting integrase inhibitor, and it is changing the treatment and prevention landscape. Now let's talk more about cabotegravir. Please go to slide 20. Long-acting cabotegravir is transformative, an opinion shared by patients, healthcare providers, and community members. This quote is from Dr. Gary Blick, a longtime HIV treater and researcher, who tells the story that patients are enjoying long-acting treatment, and they want more.
On the right side of the slide is a photo of a word cloud that I took when I was in a room with 35 U.S. healthcare providers. The word cloud was created in response to the question: What do your patients tell you about their experience with Cabenuva? Their responses articulate exactly what we hoped we could do, which is change people's lives for the better, give patients more freedom, reduce stigma, make them feel more normal, and improve their quality of life. Now, let's hear more from HIV experts and healthcare providers.
Long-acting is a game changer.
Long-acting medicines are gonna be game changing.
There is great future for long acting therapies.
I do think that long-acting technologies for both treatment and prevention are hugely transformative.
I've gone through the whole generation of patients taking handfuls and handfuls of pills, all the way into the single tablet regimen.
Long-acting therapies have the advantage of not reminding people to take a pill every day.
It's a constant reminder that I'm HIV positive, or a constant reminder that I'm at risk of HIV infection.
For women in particular, they may experience the threat of intimate partner violence. For young people, they're perceived as being promiscuous.
There's an extreme psychological benefit to say that I no longer take any HIV pills after being diagnosed HIV positive.
I hope the next decade sees huge advances in R&D, with more and longer-term and different delivery systems, and simultaneously, much greater, equitable delivery of the things that we have.
The world is going towards long-acting. The HIV medicine is going towards long-acting.
Ultimately, what we hope to see is that people on long-acting medicines are gonna be adherent, and that's how we're gonna keep them healthy.
I can't remember a time of greater opportunity.
Please start- turn to slide 21. Data on cabotegravir long-acting has dominated scientific meetings for the last several years. Key studies for treatment presented in 2022 and 2023 are the SOLAR study, the first head-to-head study comparing Cabenuva to Biktarvy, demonstrating non-inferior efficacy, improved treatment satisfaction, and a strong preference for Cabenuva, with nine out of 10 individuals on Cabenuva preferring it to Biktarvy. The CARLOS study is a real-world evidence study that reinforced the preference for long-acting cabotegravir plus rilpivirine, with 99% preferring it to daily oral. And the Ward 86 study, where individuals who struggle with adherence and consistent engagement in HIV care and whose virus was not controlled, were successfully treated with Cabenuva. Now, please note that Cabenuva is not currently indicated in individuals who are not virologically suppressed.
We are currently engaging with the FDA to determine how we can expand our label to include this population. There have also been a number of important studies of cabotegravir for PrEP, showing an overwhelming patient preference, 95% for cabotegravir long-acting over daily oral in randomized trials and in real-world evidence. Please move to slide 22. Through our innovative science, we've demonstrated our leadership in HIV drug development by launching the world's first long-acting portfolio, powered by cabotegravir. Long-acting cabotegravir has had tremendous impact on HIV treatment and PrEP. I've shown you, and you've heard from providers, that cabotegravir is innovative, game-changing, transformative, but we are not satisfied with that. Our goal has been to improve on that and deliver more for patients. So how do we improve on something so significant?
We intend to improve on the first and only long-acting regimens by doubling the benefits that cabotegravir brings, by doubling the interval between doses, and cutting in half the number of clinic visits from six times a year to three times a year, with a new formulation of cabotegravir. We've undertaken creative and intensive formulation work on cabotegravir and have developed a new formulation called CAB 400. CAB 400 is double the concentration of the current formulation and has double the half-life, which allows it to be dosed every 4 months, with the potential for every 6-month dosing. We've submitted this data for presentation at a conference in early 2024. This new formulation allows us to pursue ultra-long-acting cabotegravir for PrEP, increasing dosing intervals from every 2 months to every 4 months, which means cutting clinic visits in half.
This will allow more patients to access long-acting cabotegravir for PrEP as soon as 2026. In treatment, we will provide, we will combine ultra-long-acting cabotegravir with either rilpivirine or our broadly neutralizing antibody, N6LS, to deliver ultra-long-acting option as soon as 2027. Now, let's talk more about these two options. Please move to slide 23. Looking at option one, cabotegravir plus rilpivirine. Our intention is to expand on the use of Cabenuva to deliver an ultra-long-acting treatment, building on HCP and patient confidence and familiarity, and improving the overall patient experience. Rilpivirine has a half-life of around 200 days, and we're working with our partner, Janssen, to explore alternative doses and formulations. Please move to slide 24. Option two looks at partnering CAB 400 with N6LS. N6LS is a broadly neutralizing antibody, or bNAb. It targets the CD4 binding site.
It's one of the broadest bNAbs discovered to date, covering up to 98% of viruses tested in vitro. It's also one of the most potent bNAbs currently in development. Our proof of concept study demonstrated viral load reductions up to 2.8 logs following a single injection. Importantly, we have the opportunity to progress N6LS as part of our collaboration with Halozyme, using their recombinant hyaluronidase, or PH20 technology, which allows us to deliver a larger volume of drug via subcutaneous dosing. Our studies of N6LS plus PH20 demonstrated we can deliver a single subcutaneous dose that is well-tolerated and can last up to four months. The US Vaccine Research Center did a similar study and had similar findings. They presented that data at CROI 2023.
We presented our proof of concept data on N6LS at the HIV Glasgow Conference last year. The ability to deliver this bNAb subcutaneously with PH20 allows for an improved patient experience, where individuals do not need to have an IV or receive a long infusion, as is the case with other bNAbs currently under investigation. Our phase two study, N6LS plus cabotegravir long-acting, called the EMBRACE study, is currently enrolling, and we expect to have data on this combination in 2024. Please move to slide 25. This slide describes the HIV replication cycle and our pipeline assets by target. Broadly neutralizing antibodies target binding and fusion. Now, I've just talked about N6LS or VH109. In addition to that, we have a new bNAb, a bispecific bNAb, which means it hits two targets with one antibody.
In vitro, it covers 100% of viruses tested across multiple subtypes, and we expect that it will enter clinical trials in 2024. Capsid inhibitors target multiple steps in the HIV life cycle, nuclear entry and uncoating, and assembly and budding. We have two capsid inhibitors in our pipeline, and then they are currently in phase two trials. In the middle of the slide, are integrase inhibitors, the foundation of our regimens. In addition to CAB 400, we have two other integrase inhibitors: VH184, a third-generation integrase inhibitor with ultra-long-acting potential and broad coverage of integrase mutations. And a new integrase, VH310, which has a half-life at least four times longer than the current formulation of cabotegravir. VH184 is in phase 1 clinical trials, and VH310 is expected to enter clinical trials in 2024.
Finally, we have a maturation inhibitor, VH937. Maturation inhibitors act late in the replication cycle, similar to protease inhibitors. We've investigated other maturation inhibitors, but VH937 is a maturation inhibitor with long-acting potential. It's currently in phase one, and we expect it to enter phase two by the end of this year. Please move to slide 26. This slide provides more detail on our assets and the candidates for each target product profile. Here, we're showing that most of our assets have the potential to contribute to ultra-long-acting or self-administered target product profiles. Starting with our entities listed in gray, for example, you can see that CAB 400 is included as a potential option across all TPPs. Looking at partner options for treatment in orange, our bNAb, N6LS, is included in all the options as well.
However, the maturation inhibitor is a partner agent that would likely only meet the TPP for self-administration. Please move to slide 27. By the end of this year, we will select the dose of CAB 400 to be studied in 2024 for every four-month dosing as a part of our ultra-long-acting treatment and prevention strategy. For ultra-long-acting PrEP, the registrational study for cabotegravir every four-month dosing is expected to start in 2024, with a file and launch expected in 2026. Our wide array of entities provide a path to every six-month PrEP, but timing will depend on the asset that we select. For ultra-long-acting treatment, we expect to deliver the cabotegravir every four-month regimen, with a registrational study start in 2025, followed by file and launch in 2027....
Subsequently, we intend to partner either VH184 or VH310 with a new mechanism of action agent to deliver an every six month dosing regimen by the end of the decade. For long-acting self-administration, we are targeting every 2- 3-month dosing. We've set the bar high, seeking a positive patient experience with efficacy and tolerability that is at least as good as Cabenuva, but with the benefit of being able to administer at home. Of note, we explored the possibility of switching Cabenuva from intramuscular dosing to subcutaneous dosing in a cohort of roughly 90 individuals, and we found out the two out of three individuals preferred intramuscular dosing to subcutaneous dosing when administered by a healthcare professional. This gave us several important insights. Firstly, the current form of Cabenuva dosed intramuscularly is very well tolerated. And secondly, subcutaneous dosing is not necessarily better tolerated than intramuscular dosing when delivered monthly.
Given that we plan to have an option for clinic-administered, ultra-long-acting treatment with only two to three clinic visits per year, a self-administered regimen must deliver a uniquely valuable patient experience when compared to in-clinic treatment. Again, a high bar, but we are up to the task. We plan to select the regimen next year, which will enable device setup, followed by a registrational study starting in 2026, with a target to file and launch by the end of the decade. Please move to slide 28. We've taken patient insights and turned them into target product profiles and described how we plan to get there, providing patients with the desired flexibility to enable them to live their best lives. Our ambition is driven by people living with HIV and those who could benefit from PrEP.
Last summer, we traveled to Cape Town, South Africa, to meet and thank the young people who participated in our pivotal trials for Apretude. Here's a small part of that conversation.
22 years ago, when we first came here, and we said, "We can stop babies being born with HIV," and we did that. And then we said, "People can live a normal life when we give them antiretrovirals," and we did that. And today, we claim that we can stop people getting infected with HIV, and we will do that.
We need it. We need it to bring back our worth, like, to bring... like, to empower others even, and to decrease the escalating numbers of us as young women infected with this virus.
We could not have done this study without partnerships. So those partnerships, that commitment, no, nobody could do this on their own. This is all about partnerships, private company like us, academic environment, community, all of that coming together to make something so incredible happen. What it means is that we have something that is remarkable for women that will absolutely change the game. There's no question.
We now have the opportunity for choice.
Having a choice, oh, man, I cannot explain the feeling, but Emma and Lena, or let me, let me say the team, has made something, like, has come out with something for us to use. Like, they have brought rescue.
And, I just, I feel so proud of all of these young women who were in it, stuck to it, came to their visits, didn't mind a shot in their bum, went on, made sure that this was a success. Do you feel like it made you feel empowered?
It has strengthened me, it has empowered me, it has shown me how worthy I am.
I love that. I love that. I love that. What I want to say is, thank you. Because of you and all of the people like you, who were willing to give of yourself-
Mm.
To be a part of this trial, we're gonna change HIV for the world.
I think that-
Can I have a hug? Thank you so much.
Thank you.
Thanks, Kim. We're on slide 29. Please turn to slide 30, where I will summarize our updated commitments. We've confirmed that as a result of our strong and competitive execution and innovation leadership, we will upgrade our 2021-2026 sales CAGR from mid-single digits to a higher range of between 6%-8%, which includes the estimated impact from the U.S. Inflation Reduction Act of up to one percentage point of growth. Dovato, Cabenuva, and Apretude will each deliver significant benefits for people living with HIV or those who could benefit from PrEP. We are confident that Dovato and our long-acting injectable portfolio will each deliver more than GBP 2 billion of revenue. As we move into the second half of the decade, cabotegravir will replace dolutegravir as our foundational medicine.
We expect to see a significant acceleration in the uptake of our long-acting injectables, which allows us to be confident in our ability to navigate through the revenue impact associated with the loss of exclusivity of dolutegravir. As a result of strong pipeline progress, we expect it to deliver a new long-acting formulation of cabotegravir, which has the potential to double the dosing interval in prevention to every four months in 2026, and in treatment in 2027, enabling people to reduce clinic visits to just three a year for the treatment and prevention of HIV. We have also outlined a clear roadmap to further extend the dosing interval of our long-acting regimens in treatment and prevention to enable every six-month dosing towards the end of the decade. This would result in people only needing to visit the clinic two times a year.
Finally, we are confident that we will consolidate our position as innovation leaders and deliver further growth in our long-acting portfolio in the next decade, and we remain fully committed to our mission to leave no person living with HIV behind.
So, with that, we will take the first question from Richard Parkes at Exane. So, Richard, over to you, please.
Hi. Thanks, Nick. Yeah, I suppose, so sticking to the one question, could you just tell us a little bit more in terms of CAB 400, around the n-number of injections and the needle gauge, and the device, and then maybe what you need to achieve to transition that to every six months would be very helpful. Thank you.
Great. Thanks, Richard. I think we'll go straight to Kim.
Thank you for the question. So I won't get into the details of the needle gauge because we are still finalizing the dose, but I expect it will be similar to the needle that we use for Cabenuva now, so don't expect it to be a larger needle. And again, with that needle, we have very good tolerability. So with regard to self-administration, it may be that we use CAB 400, but as I mentioned, the other integrase inhibitors are possibilities for self-administration as well. You have to get the ideal volume, the ideal tolerability, and the ideal device. And so we're pulling all of those things together as we gain more data on each of the products.
Then the number of injections for CAB 400, is that two separate injections every 4 months?
Nope, one injection.
One injection. Okay. Thank you.
Thanks, Richard.
Thanks, Richard. Graham, Graham Parry, can we come to you, please?
Great. Thanks for my question. She was talking about the IP protection. So, you've sort of formally said you think you could get Juluca, Dovato protection into 2030. I think the patents expect to protect out to their combination formulation patents, and those have, I guess, traditionally provided fairly weak protection to combination products. So what gives you the confidence to say you could get... You, well, you think you will be now protected to 2030? For example, can you see all filers? Have you settled with all filers? Is there something which blocks others from the market through, you know, first to file and having been settled with, for example, you just could, perhaps just give us a bit more around the legal strategy there. Thank you.
Okay, thanks, Graham. We actually said December 2029 for Dovato and July 2030 for Juluca, but we have reasonable visibility. But Deborah, do you wanna elaborate?
Yeah, thanks. So, just to kind of reiterate, so, the dolutegravir kind of composition of matter patent in the U.S. is April 2028. In Europe, it's July 2029. We then have formulation patents for Dovato and Juluca. Dovato, December 2029, and Juluca, 2030, and that's July 2030. And actually, we've had a number of generic submissions. We've settled the ANDAs, and, you know, we feel confident that those, that those formulation patents, you know, are hold, will hold and give us that coverage to the dates that we've mentioned.
Thanks, Deborah. Can we take the next question from Emmanuel Papadakis, please, at Deutsche Bank? Over to you, Emmanuel.
Thank you, sir. Maybe a question on the key for treatment options. It looks like, correct me if I'm wrong, but only option two is subcutaneous. So the question, you seem to be alluding to 98% coverage, but I, I think some of the data we saw presented earlier at year suggests that it might be somewhat less than that. So just your confidence on the breadth of clade coverage and the need for testing to assess which patients might be suitable for treatment with that single bNAb. Thank you.
Mm.
Thanks, Emmanuel. Kim?
Sure. So you're referring to the N6LS. And so, yes, the 98% that I was referring to is in vitro, and so that's based upon the, you know, the panels that all of the broadly neutralizing antibodies are tested against. And so that is a- that's one of the highest breadth of all of the bNAbs that have been tested using that testing. Now, in vivo, we expect those numbers to be lower, and I can't tell you exactly where we will land there. But so there will be a need for a test to make sure that individuals are sensitive to the broadly neutralizing antibody before individuals receive it, and so that is the plan for N6LS.
Kim, is it worth just confirming the administration of the two options that we've got? Because I think Emmanuel referred to how IM versus subcutaneous. Is it worth just clarifying, of the two options, how they're administered?
Sure. So, for broadly neutralizing antibodies, again, what I mentioned was that we can use it in combination with the hyaluronidase, Halozyme's hyaluronidase or PH20. And that allows you to give a subcutaneous injection instead of having to give an IV infusion, which is the case with other broadly neutralizing antibodies that are being studied. And so one subcutaneous injection lasting for four months. So with cabotegravir, our intention is that we'll be dosing every four months with an intramuscular injection, because we have found that to be actually extremely well tolerated.
Just worth emphasizing also, Emmanuel, remember that N6LS is one of two options we have to partner with CAB 400, the other being rilpivirine. We'll make a decision on that next year. Great.
Thanks, David, and thanks, Emmanuel. Peter Welford, can we come to you next, please?
Hi. Yes, thanks. I do want to come back to actually the every four-month dosing. And just so I understand then, if you pursue option one, am I right in saying then that will still be two, as it currently is, two, if you like, IM injections, one of CAB 400, and one of the rilpivirine, which it sounds as though you're also going to try and reformulate. And I guess I'm curious to know how... Is that the similar sort of idea to CAB 400, for then the second IM, presumably, injection? And then am I right in saying the second option would be an IM CAB 400 every 4 months, but then with a subcut the VH109, together with the Halozyme technology.
So again, two injections, but that's having one IM and one subcut. Is that the right way of thinking about it? And I guess, are option one and two both on the table, or will only one of those go into a registrational trial, just to be clear? Thank you.
Thanks. Yeah, great question, Peter. Yes, you do have it. You do have it correct. So our intention is that we would have a regimen that's very similar to the current Cabenuva, except that they would come in three times a year, and, for option one, they would come in three times a year instead of six times a year. And so, yes, with two injections, that is the intention. And, and again, as I mentioned, we're working with our partners at Janssen, for getting to, getting to that right, that correct dosing interval, with rilpivirine. As I mentioned, rilpivirine already inherently has a 200-day half-life, so it has a very long half-life that certainly makes that a possibility. The second part of your question, I think, was regarding, the combination with N6LS.
Yes, you're right, it would be IM cab, cabotegravir, along with the subcutaneous N6LS. So our intention is not that we would launch both. We will make a decision about which of those two has the best profile next year, and, and move that into late stage registrational studies following that.
Thanks, Kim. Can we take the next question from Kerry Holford, please, at Berenberg? Over to you, Kerry.
Hello, thank you for taking my question. My question is on the guidance. Today, you've upgraded that 2021-2026 outlook. The footnote there states that you include an estimated GBP 200 million of annual impact from 2025 relating to IRA. I just wonder if you can walk us through how you get to that figure, what your assumptions are behind that GBP 200 million pound headwind in 2025. Thank you.
Thanks, Kerry. Deborah?
Yeah, thanks for the question, Kerry. So, in terms of the Medicare Part D redesign, we are assuming that our Medicare Part D products, which are our orals, Tivicay, Triumeq, Juluca and Dovato, will be impacted by the element of the redesign that holds manufacturers accountable for 20% of the catastrophic phase of the treatment. So you have kind of a whole year's coverage. In the first section, you kind of have a threshold where you get to about $6,000 of cost, and then after that, the manufacturer becomes responsible for 20% of the cost. So that is where you get to the $200 million. We haven't factored any other elements in, because they're not really relevant to you know, to our medicines.
There is a small impact on Part B, which is Cabenuva and Apretude, but it's really small. The main area where we've got impact due to the catastrophic coverage is on our orals.
Thanks, Deborah. We're going to take our next question from Andrew Baum at Citi. Andrew, over to you, please.
Thank you. I apologize if you addressed this at the beginning of the call, that I wasn't on. I'm just curious why you're not prosecuting a 12-month formulation of cabotegravir or prodrug of that, given there clearly are examples of where the pharmacokinetics would lend themselves to this. Is this a life cycle strategy, that you're reserving that for your next generation integrase? Or is there some other reason why the 12-month PrEP is unappealing?
Thanks, Andrew. Kim?
So, thank you for the question, Andrew. We are evaluating. As I mentioned, we have VH310, which has four times the half-life of CAB, and we are looking to evaluate that and get that into patients next year. Once we have data in patients, if we can get to 12 months, we absolutely will pursue that. But we're not, at this point, over-committing on the basis of not having seen the results of that product in humans yet. And so we certainly wouldn't take it off the table for the future if we deliver that PK in humans. But at this point, you know, we haven't started clinical trials on that product yet.
Great. Thanks, Kim. We're gonna take our next question from James Gordon at J.P. Morgan. Over to you, please, James.
Hello. Thanks for taking the question. It was just lenacapavir from Gilead, and how to think about that, because I think that their capsid is being developed as a 6-month injection, both as a prevention and a treatment, and also a weekly oral treatment. So just how you would see that comparing with the offerings that it looks like you're likely to go with? And if they do get their 6-monthly launch ahead of you, which I think they're already, at least for prevention, already in phase three, then what would drive patients to then move towards your preferred offering if you subsequently launched them?
Thanks, James. We obviously think about that a lot. Kim, do you wanna maybe start with prevention?
Well, let me start with the fact that, you know, we have a long-acting prevention agent on the market now, and so providers and patients are gaining experience and familiarity with Apretude today. Our plan is to be able to actually extend that, so that they are coming in instead of six times a year, down to three times a year as soon as 2026. And we have an ambition to get to six-month dosing, at least, in the future, by the end of the decade. I think, you know, the comparison to lenacapavir is an interesting one, but I would just say first, they have to finish enrollment of their clinical trials, which they're currently not completely enrolled, and they have to demonstrate efficacy.
And we have set a very high bar because we've shown efficacy, and not just efficacy, but superiority in comparison to daily oral. So we've set a very high bar. The other thing to note about lenacapavir is that it is two subcutaneous injections, and in some cases, individuals may experience some skin sequelae from those subcutaneous injections. Bruising, nodules, redness. And so the tolerability profile of that product in comparison to our product, I think, would be very key when they are both on the market. That's assuming that lenacapavir is able, again, to demonstrate appropriate efficacy. So we're very confident at that Apretude because it is really extremely well tolerated, and again, we're getting to a longer interval, which will be very appealing to patients.
Do you want to say a little bit about the competitive...
Yeah, just-
Sorry, Deborah. Competitive landscape in, treatment as well?
Yeah, I mean, in the treatment space, you're right, there is a study using lenacapavir in combination with islatravir, dosed weekly. Obviously, islatravir has to overcome the toxicity challenge that was demonstrated in the past couple of years, where it has shown lymphocyte toxicity. We'll see if the lower dose, which the dose that they're using now, weekly, is essentially tenfold lower than the dose that they were originally planning to use. So does it have the efficacy when it's dosed weekly, and does it have the tolerability profile? So I think that question has to be answered in their clinical trials. But with regard to long-acting therapy, so you know, we're heading towards...
We're already at 2 months, we're heading towards 4 months, and I expect that we will launch our second-generation, long-acting, regimen, injectable regimen, before they're able to launch their first one, because lenacapavir is, at this point, looking for a partner agent. And so, you know, we have been the leaders in this space, and, you know, we're very, very proud of that. And we're actually happy that our competitors are following us down this path. But I think it's very clear that we have shown leadership here.
Thanks, Kim. Okay, we're gonna take our next question from Eric Lebrego at Stifel. So, Eric, over to you, please.
Thank you, Nick. The question is to try to clarify a couple of things on the guidance, please. Because you're sticking with the 2021-2026 period, and so into this, we have 18 months behind us, where you delivered 12% growth. And so for the remainder, to reach the 8%, we only need 5% for the next three and a half years. If we take the GBP 7 billion in sales that you expect in 2026, and we extrapolate the first half into 2020, the full 2023, we may be at GBP 6.4 billion at the end of this year, and then reaching seven would mean 3% for the next three years.
So the question is, why should we think about such a slowdown before the first part of the period and the remaining part of the period? Thank you.
Thanks, Eric. Deborah can explain that.
Yeah. So, obviously, we have performed extremely well, over the last kind of two and a half years, and we're very ambitious for our kind of future growth. Towards the end of the period, you have the impact of the Inflation Reduction Act. And we also have a few international markets, most notably Russia and Brazil, where we lose the patent of dolutegravir in 2026. So there is some drag on revenue, which leads us to believe that the six to eight CAGR is the sensible upgrading guidance to give. All of that is factored into that guidance.
Obviously, we're giving a sensible range that we believe is achievable, but we remain extremely confident in the future trajectory of our business, particularly, you know, the rapid growth that we see in the long-acting injectables.
What's definitely true is we're very pleased about the real momentum that's in the business today. As you said, double-digit growth last year and up 14%, in the first part of this year. A lot of momentum in the business.
Thanks, David. So just as a quick reminder, if you do wanna ask a question on Zoom, please do raise your hands using the icon in the menu bar. And also, if you joined on the telephone, please remember to press Star nine to register a question and Star six to unmute. With that, we will come back for a second round now. So, Richard Parkes, can I come back to you, please?
Thanks, Nick. Yeah, largely clarifications, actually. Just, just on the guidance, so I can I just clarify that the 6%-8% CER guidance is broadly consistent with where consensus is, which I think is about GBP 7.3 billion in 2026. So despite that pressure from IRA over that period. Then the second question is on clarification of the subcut, the self-administered product, because I think you we've now got a kinda good view of what the, the treatment prep kind of products profiles look like. But I'm, I'm still a bit confused about what the, the scenarios are for the self-administered.
Right. Anything to add on guidance, Deborah? I think you're exactly right, Richard.
I think Richard's right. I mean, we're we think an upgrade from GBP 6 billion to GBP 7 billion in 2026 is very positive. It's based on really tremendous performance, a competitive performance from our long-acting injectables and also our oral two-drug regimens. And we think that, you know, that 6%-8% guidance is positive because it accounts for all the headwinds and at the same time reflects the opportunities that we see before us. And as you say, you know, consensus is broadly in the same, you know, the same range for 2026 in terms of around GBP 7 billion. So, I think we feel very confident in that guidance, and happy that we've been able to upgrade it.
Great.
Great. Thank you.
Do you want to talk about self-medication and,
Sure. Sure, yeah. Just to be clear, so, for self-administration, it will be a—it will most likely be subcutaneous dosing, using an auto-injector. As, as you know, most of the auto-injectors dose subcutaneously. And so what we are looking to do is use a, you know, a, the foundational entity, one of the three options, that we have, most likely either cabotegravir or VH184, and use that in combination with one of the novel mechanisms of action. And, again, we're targeting 2-3 monthly dosing. But yes, it will be subcutaneous dosing for self-administered. For the 4-month dosing, and just to make sure that that's clear.
For the 4-month dosing, depending on whether we choose the rilpivirine option or the N6LS option, the cab dosing will be intramuscular, and then rilpivirine is likely would be intramuscular as well, and then the N6LS would be subcutaneous, with PH20X as a subcutaneous injection. So I hope that that's clear.
Thanks, Kim. Graham Perry, we'll come back to you now, please. So, you're able to talk. Over to you.
Yeah, great. Thanks. So actually, I had a follow-up on the self-admin timelines as well. I think you'd originally said 2025-2027 launch timeframe, and I think you'd said you had a 2 ml formulation of cabotegravir that you're pretty comfortable with. So is the issue on the delayed 2028-2030 launch here, the device? So perhaps you can just give us a little bit more background to which device partners you're working with, and if that's what's holding up and what the issue is there. Secondly, on six-monthly plus, if that's able to come in the sort of 2028-2030 timeframe with VH184, that's only like a year or so after your sort of timeframes on four-monthly.
So, would you launch both and have both in the market at the same time, or is there a possibility you end up dropping four monthly, to actually just progress? And on that, are you in clinic with injectable VH184? And I think that was due to go in Q4. And then... sorry, last one is, just I think you'd also talked about a weekly oral VH184. I think that was also in phase one. You don't mention weekly oral as an option here, so have you, have you dropped that as a strategy now? Thank you.
Okay, that was a lot. All right, let me, let me start, let me start with the question around 2025. Yes, we did originally talk about the potential of bringing the self-administered earlier, but in that case, we were, we were looking at dosing monthly. And what we ultimately decided was that as we get to longer and longer intervals for ultra-long-acting, every 4 months, every 6 months, where individuals are only coming into the clinic twice a year or three times a year, that the, the, the proposition, the comparison, just one month wasn't enough, and so we've raised the bar and said, we wanna have a, a self-administered that's at least 2 months or 3 months, so that it's more appealing. And so that is, that's part of what's caused the delay.
And then with regard to the device, it is, it's always important, obviously, to pick the right device that will allow you to have the volume that you need to get to the intervals that you need. So it's the combination of really us setting the bar higher, and that really not being able to move that monthly, just not seeing that monthly as being the right way to go forward, that has pushed the timeline back. With regard to the next question.
184, what, first time in humans?
Yes. So VH184, first time in human oral, is an ongoing study. The injectable formulation of VH184 has not entered the clinic yet, but is soon to enter the clinic, and so we'll have some data on that in 2024. And so, you know, we expect to get a lot of our first time in human data from the injectable formulations of VH184, the capsids. That data is going to come in 2024, which is what's gonna enable us to make those regimen selections for the to move forward into later stage studies.
David, can I just make a comment on... Oh, sorry, Kim, I thought you'd finished.
No, no, go ahead.
I was going to comment on the market after you finished. Sorry.
No, no, no. Go ahead, Deborah.
So I was just gonna comment on your, or answer your question on the market, Graham, because I think it's a really good one. So Kim's setting out lots of options, and we will make choices, as we've said previously. The HIV market over the next kind of, you know, five, six, seven years, is slow growing, and let's say it's relatively fixed at around GBP 20 billion of value. And within that market, every time a new competitor or we put forward innovation, we have to decide, is that innovation good enough to launch, both in terms of the patient benefit it brings and also the shareholder value it delivers, from a return on capital perspective.
So I would think of it as a, as a set tie, and what we need to do is every time something gets better, long-acting intramuscular injections every 4-6 months, the bar goes up for the, you know, the other, e-elements that you could launch into the, the market, such as the, self-administered or even weekly orals. Because the bar is getting higher all the time in terms of the, the profile of the medicines you're developing, and that means that the self-admin at 1 month probably isn't good enough. We now need to be at least every 2-3 months, and that's why we've chosen to go for a best-in-class approach, because otherwise the share it would take is less, you know, beneficial financially because every four months and every six months is just so compelling.
So I think that's how we should think about it. We will make choices, and it will be made according to what the profile of the medicines that we develop look like. If we can't hit a high enough bar for the self-admin, because we've got so far ahead on the intramuscular, so, so we may make a choice between the two classes. Or if every six months is rapid and compelling, we may not launch every four months, but we'll definitely do it through the lens of patient benefit and return on capital invested. I hope that makes sense, but I think that's an important way to think about the market.
Yeah. That's super clear, actually. And weekly oral, is that still an option?
Yeah.
We're looking at weekly oral, aren't we, Kim? What... Kim, do you wanna talk about that?
Sure. So we're, you know, we're evaluating every one of the products that are in our pipeline for the potential for it to be weekly oral. And if we determine that we have products that look like they meet that profile well, you know, we will consider adding that as a target product profile. But for now, we are just keeping... Really, basically, just keeping an eye on the products that we have in the portfolio. And so we will keep you posted if we make a decision to take on that target product profile.
Great. Actually, one quick follow-up. You'd mentioned, obviously, the capsid maturation inhibitors on slide 25, but they're not in your option one, option two. So are those only for combo with the VH184 later, or are those ones that you might put into cabotegravir combination still?
Yeah. So capsid has the potential to do all of the above. So it could be six months. What our expectation is, it's also the long-acting version of it is just entering the clinic. As I mentioned, it's now in phase 2. Long-acting version is just entering the clinic, so we'll look to see what that data is. But our expectation is that it could potentially be responsive in all three of those target product profiles. The maturation inhibitor, on the other hand, though, we don't believe that it will have the half-life to allow it to get to be every six months, and so it would be focused on the self-administered profile.
Great. Very clear. Thanks very much.
Thanks, Kim, and thanks, Graham. We have a question now from Andrew Baum again. So Andrew, over to you, please.
Thank you. Could you talk to bridging where appropriate? I would imagine that when you're injecting in the same compartment, bridging is gonna be relatively straightforward from a regulatory point of view, but I can't imagine that subq to IM bridging is gonna be allowed or maybe not. If you could share your thoughts, that'd be helpful.
Kim?
So, obviously, that's always subject to engagements and negotiations with regulatory agencies, but it is certainly true that for cabotegravir, for PrEP... What we are looking to do is extend, essentially extend the interval, but so the same method of delivery, with a product that just lasts longer. And so certainly, PK bridging is an important part of that strategy to allow us to get that option to patients as quickly as possible.
Thanks, Kim. Looks like Kerry Holford has also come back for a second round. So, Kerry, to you, please.
Thanks to you. Another more financial question from me. Just thinking about the various combinations, novel molecules you've got coming through. Can you talk to any potential meaningful payaways you need to consider when we're thinking about modeling these assets, in the longer term? Thank you.
I think it's mainly on rilpivirine, Kerry, but Deborah, do you want to elaborate?
Yeah, sure. So, on the integrases, it's fairly straightforward. It's the same deal with GSK as we've always had, so the payaways are the same, as on dolutegravir, and on the current version of cabotegravir. And obviously, you know, you've got their, their follow-on, compound as well. In terms of the payaways, so yeah, there is a payaway to Janssen on rilpivirine. There is a limited, payaway on the bNAb to the NIH. And there is, obviously, as we've shared previously, a payaway to Halozyme if we use PH20, but they are obviously at, at much lower levels. So there are varying amounts of payaway on each of the different molecules.
The material difference is whether or not we have rilpivirine or one of our own in-house developed assets as the partner to cabotegravir or VH184, and that obviously remains to be seen over the clinical data that we generate in the coming months and years.
Can you quantify the level of those payaways on the bNAb? Can you say them on this side and Halozyme also?
So, Nick, have we shared those things? I don't think we've shared them specifically, have we?
We haven't, but Kerry, what we'll do is we'll come back to you offline, if that's okay.
Yeah.
We'll certainly make an addendum just to the transcripts just to help people. I think that's probably the easiest thing to do. With that, can I take another question, please, from Richard Parks? Richard, over to you.
Thanks, Nick.
Yeah, you're welcome.
Yeah, sorry about that. So it's just a follow-up from Graham's question earlier on about the strength of the patents protecting Dovato and Juluca. And it's a slightly different sort of way of thinking about it. I think sometimes we're seeing generics try and get around those kinds of formulation patents by maybe co-packaging two separate pills in order to get around that. I don't know how successful that has been in the past, so just wonder if that's something that we should consider and what the precedent suggests that in terms of impact that's had on drugs when going generic in the past. Thanks very much.
Deborah?
So thanks, Richard. So you can split, as you say, the components of the medication. So let's say Dovato, you could have, you know, dolutegravir and lamivudine, both of which are generic or will become generic in separate tablets. That has been done in a few parts in Europe, and it has been unpopular. But in the UK, for example, there was a very strong push through the NHS, and in some parts of the UK, there was uptake. In the US, where that has been proposed, it has not been successful, because obviously we're trying to enhance patient adherence and support viral suppression across the healthcare system. At the moment, viral suppression is very poor.
From a 1990 goal, the US, if you look across people who are diagnosed, people who are treated, and people who are virally suppressed, you get just over 50% of people who are, you know, living with HIV virally suppressed. So I think splitting is unlikely in the US, which is where this extension sits, so it's US only, because people are trying to drive greater levels of virus suppression, not undermine the kind of the goals that we've currently got or the offerings that we've currently got in place today. So I would say splitting is very unlikely in the US. It may happen in Europe, but we don't have the additional coverage for Dovato and Gilead in the US, so I assume that that market will just move straight into generics.
Perfect. Very helpful. Thank you.
Thanks, Deborah. So at this point in time, we have no further questions. So what I propose is if we just quickly come back to you, Deborah, just to wrap things up, and then we'll close the call.
Thanks, Nick. So I hope from the call today that you can feel our confidence in the momentum of our business, between, you know, due to the upgrade from our 2021 to 2026 CAGR to 6 to 8%. I hope you're feeling very positive, as we are, about the momentum in our long-acting injectable portfolio, which will be 40% of our business in 2027. And we believe that we have a really strong set of offerings with our pipeline, particularly now with the opportunity of every four months and every six months in treatment and PrEP, and obviously the progress we're making on self-admin, which will see us through the loss of exclusivity of dolutegravir.
So I hope you felt our confidence and our enthusiasm and, of course, our commitment to leaving no person living with HIV behind. So thank you for your time this afternoon.